RESUMO
Objective To acquire specific suggestions for improving the transparency of clinical research.Methods Summarize main challenges for transparency in clinical research,propose possible solutions.Results Currently the common practice of clinical research transparency is to promote study registration in the beginning phase,and reporting guildlines,data sharing in the end phase of the study.The main challenges identified in clinical research transparency are (1) lacking awareness of transparency among investigators,(2) poor data integrity and traceability of research data resulted by the ignorance of transparency during study implementation process.To face the challenges,investigator should be more proactive and related research administration should be streamlined.Conclusions To improve the transparency of clinical research,better understandings of the concept of clinical research transparency for investigators and whole-process supervision from the administrative aspect should be strengthened.Furthermore,advanced information technology should be adopted to construct a hospital-based source data platform for complete clinical research process management,it helps in promoting research data quality and could become a suitable tool for clinical research administration in hospitals.Ultimately,full research transparency would be achieved.
RESUMO
Objective@#To establish comprehensive laboratory reference intervals for Chinese children.@*Methods@#This was a cross-sectional multicenter study. From June 2013 to December 2014, eligible healthy children aged from 6-month to 17-year were enrolled from 20 medical centers with informed consent. They were assessed by physical examination, questionnaire survey and abdominal ultrasound for eligibility. Fasting blood samples were collected and delivered to central laboratory. Measurements of 15 clinical laboratory parameters were performed, including estradiol (E2), testosterone(T), luteinizing hormone(LH), follicle-stimulating hormone(FSH), alanine transaminase(ALT), serum creatinine(Scr), cystatin C, immunoglobulin A(IgA), immunoglobulin G(IgG), immunoglobulin M(IgM), complement (C3, C4), alkaline phosphatase(ALP), uric acid(UA) and creatine kinase(CK). Reference intervals were established according to central 95% confidence intervals for reference population, stratified by age and sex.@*Results@#In total, 2 259 children were enrolled. Finally, 1 648 children were eligible for this study, including 830 boys and 818 girls, at a mean age of 7.4 years. Age- and sex- specific reference intervals have been established for the parameters. Reference intervals of sex hormones increased gradually with age. Concentrations of ALT, cystatin C, ALP and CK were higher in children under 2 years old. Serum levels of sex hormones, creatinine, immunoglobin, CK, ALP and urea increased rapidly in adolescence, with significant sex difference. In addition, reference intervals were variable depending on assay methods. Concentrations of ALT detected by reagents with pyridoxal 5'-phosphate(PLP) were higher than those detected by reagents without PLP. Compared with enzymatic method, Jaffe assay always got higher results of serum creatinine, especially in children younger than 9 years old.@*Conclusion@#This study established age- and sex- specific reference intervals, for 15 clinical laboratory parameters based on defined healthy children.
RESUMO
Objective To compare the predicted efficiency ofmacular hole closure index (MHCI) calculated by 2 different methods for postoperative anatomical outcomes after idiopathic macular hole (MH) surgery.Methods This is a prospective exploratory clinical study.A total of 63 patients (63 eyes) with idiopathic MH,who received vitrectomy,inner limiting membrane peeling and gas tamponade,were enrolled in this study.All the patients received optical coherence tomography (OCT) examination at each visit to measure the MHCI using the formula MHCI=(M+N) /BASE,M and N is the distance from outer limiting membrane break points to the beginning points of detached photoreceptor from retinal pigment epithelium of both side of the hole,respectively.BASE is the length of MH base.MHCI1 was measured by built-in caliper of OCT software,MHCI2 was measured by ImageJ software.The minimum macular diameter (MHD) was measured by built-in caliper of OCT software.Based on the OCT images,the anatomical outcomes were classified grade A (bridge-like shape closure),grade B (complete closure) and grade C (poor closure).Grade A and B are considered as good closure,grade C as poor closure.Patients were followed up at 3,6 and 12 months after surgery.The closure grades at last visit were the final outcome.The relationship between MHCI 1,MHCI2 and closure grades was analyzed.And the predicted efficiency of MHD,MHCI1 and MHCI2 for anatomical outcomes after the surgery was studied.Results The mean MHCI1 was 0.68±0.21 (0.30-1.35),MHCI2 was 0.95±0.26 (0.41-1.55),and MHD was (476.24±210.18) μm (127-956 μm).MHCI1 and MHCI2 were both negative correlated with the closure grades (r=-0.665,-0.691;P＜0.001).The receiver operating characteristic (ROC) curve analysis ofMHCI1,MHCI2 and MHD for the prediction of good or poor closure showed that area under the curve (AUC) was 0.928,0.957 and 0.916 respectively,and 0.505,0.67 and 559 μm were set as the lower cut-offvalue.The sensitivity was 96.2％,92.3％ and 90.9％ respectively,and specificity was 81.8％,72.7％ and 76.9％ respectively.Accordingly,the ROC curve analysis for the prediction of grade A or B closure showed that AUC was 0.840,0.847 and 0.653 respectively,and 0.705,0.965 and 364 μm were set as the upper cut-off value.The sensitivity was 80.0％,82.9％,63.4％ respectively and specificity was 75.0％,85.7％,65.9％.Conclusion MHCI1 and MHCI2,measured by built-in caliper of OCT software or ImageJ software,both have good predictive efficiency for the anatomical outcomes of MH surgery.